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`Seriai ND. 13/"; ’9,?":4
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`pizartmaceuziszai and ms.edis:aE
`
`of the comp03itiot'a, based an the assumption that
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`$316:
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`c/ompcgiiion is in bioiagécaiiy 2fi<.‘.¥.§‘v‘{‘i arrtourtts.
`
`herflctm, it és my <>;::ir:i<;re that this patent is
`
`directad it} a ‘r_:ioh?>gi<:a1Ey e3f‘§2:<;tive amount of the: c.mm_>os:§1s.m:.
`
`
`j§_‘§:<: ‘White I}ec§_2_x;§_:;;:i,ion cf E§v’ig3;m;§_1_, 201} C:)ta§Et;1__a_§;;e§_;t_E_;_agj:__;§”'§;_:;_:_g;__:5g§<';§:x
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`EC Bees ,N0tm§;g_m;:in 3
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`Biefiggiczaiiw ‘§§Zfi"£ctiy_§___(é§ma::ni sf §§__?h1)§§)§$_§_3_§§_Q.i§§ Containing Two :33‘ EPA and DHA.
`
`16.
`
`E have read tbs Decimatiorg tr-f’ Eéari
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`Wtsite sttbnfitted on é“viay 31, 30$ '1
`
`in sL1ppor‘=. of the
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`"343
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`]‘v'Ey scientific opinion of this deciarati:“:n is that Dr.
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`‘»2v'hit£:
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`].'.'>t‘{_3§‘_‘e§i!‘5}/' <:;cmc;’m-dad
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`that ‘Be:~;a_:ci0in I flees not contain .3 biologicaiév c3ff::(;tiw3 amotznt ofa phosphokipéd containing
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`two of E.P;~‘x and DHA,
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`E.”/‘.This wading is necessitated by not only Dr
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`‘~2'w’h‘:t.c:".~% stataartaents but
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`21350 a :‘&.>.=asona*:>?'c:
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`inter;3r'<-:ta':ion by a sciemis=. in the field.
`
`533
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`As to the iatter,
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`I do n-:31, nor weutd zmy other sci-zntzst,
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`ir=.‘:-sxprat Ur. Whiifis cenctfiusic-n
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`mrzan that trans am0ur:=t:=, of the phosphtsiipid cantaining two Of EiPA and DHA are, nut prctsartt
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`in B:_>.aud{:»ir:
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`<3.-,5§.. As a vetrsran sciczntist,
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`White wcmid rim
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`such a definitive
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`stataznent, nor woutd a typiczai sciczntist draw su<t.fr: at «:;0m.:E‘usiC>n. On the corttrary, a scientist
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`woufid 100?»: at the: White d':'1’t'£i and imderstand that his c0:'scE:.:sion was tE*:at,, on the whcflet and
`
`limited by the mstruma-.m;ai <:av~s:3,ts that coma with 'c*,ver§.-‘ e.x;;>erimsE.nt, bioiogizzailv :3ff<':c.tiw3.
`
`amounts ofthe cejniposiiiran were amt 5es.E:.c; ed.
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`E9, Dr. Wiwite €.X;>1ic.it?_$,'
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`states this as he: raports his "‘«3pin§0n that the Beatadoén Oi} Fmctiozzs
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`s'e.c-cived and
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`by [‘Dr. White] do not contain PLS {;isi':tv5p}:
`
`0
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`E=§pi<.is} whim haw:-. attached
`
`to them DH/—‘», and ’;f}'§~§...='?.~., E33‘.-'5‘s and EPA5 DHA. and EPA £3!’ EPA and E3}-EA_._ _‘_.a_‘i“‘fi:?_§;_‘§}§;_Ef;_{'IL
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`4
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`iimiis d2s<:1'iEtsa-.d 2:2:-ave in mraora E: ? outiinérw. LC/MS and ‘:\/15%/MS? techt1i.('u€:.s"," White
`
`Dacia:-atieazt <}:"Ev1ay 3 ‘L, 2021,? E3 {ant-pttasis added}.
`
`xx; .9 "I‘}*,eref«3re, the 03:13: reascvzaable (‘S-miézig of the Earl L.
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`‘\?v’§1§i:: Deciaraticrx of Tviay 3 I, 1200i 1
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`is
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`that Dr. White ccmaziudad that: Beaudoin 1 does not szcmtaén 3 b.i<_>i:,:gi;iaEiy cg-.ff1:*<c.tiv£: 2:n‘;c=L=:“-.t of
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`E1 pho3pholé.;3id <‘,O!“sI':‘5i.T1i!‘:g two of EPA arm? iZ>H£\.
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`000005C.)
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`000005
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`Aimrrseg» Baeiéei Na. N Ei‘P?'£~(}{}1,"‘C=T:UE§ 333663-'2G}3
`Seriai N43. 13:’? S9,??4
`
`2?,
`
`The Ciumiersen Deeiaraiieza ehailengees the c.0ncix.1si0ns of Dr. W}'1i?:e by asserting that some
`
`amount r31’:he ;3h<;s:p"ne.-Eipi:‘i mnteyming we of EPA and DHA is preseszt in ihi’. Beaudeén oifi.
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`Howeve-r, this declaraticm does not quamify the arno‘-.m£. detached and u:§.es .3 very‘ 5er1si£%ve
`
`trzchmque (MRM mass spec.ir<:-me€ry}
`
`iisr Eh»:-. d.e‘Ie<:%i0n. This teszhnicgue eicme
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`that 2:
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`\-=e2'y smail amount hf ‘;he £:Om;?vCwSiF.iOF:., if any,
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`is preseh=;
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`in the Beaudein <3-ii, a»:eo:'dis:g its
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`Gundersera. Hovex.»e ,
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`21
`Beaudoir: oii iacsiw
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`deecyibed above,
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`:51-5: reaggnabie :'r3ading_ of Whiie as not
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`my, ever: dc» mi;-zimis‘, amouni mus c<3mp0:~;i€i<3n ofihe ‘348
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`the
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`but
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`that there mi" 3: Taioiogicaily effesziive amount 439:‘ me ::.cJ>mpc+si:i0s';_
`
`_,
`I
`. By w;:«w efzmalogy, in the Uraited
`
`when a vitamin er minerrtaé
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`preserat in a pr<_»,¢*Z=.1e:
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`hzss than 2‘?/is of R_<::c;<>m.mended Effiaiiy Inta§<e (R EIHL such a vaiue man» be repeated on 3. food
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`or with
`zastesisk that re§e.:rs a<:- the staaernent “‘Ce.3_ratains Eess {ban 2% of the
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`‘xfaaue at ibis {thest-3,: nutrient. émzzrxersts).
`a seconc anaia-gy, AS422‘,
`the
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`/—\.E::;o,
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`E,}z::i_3,»
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`requestoz‘ an U.S%.S.E\3. 95fOO‘s,7‘74$ has r-eeeived a (}enera5‘;y Rctegcnized as Safe. {GRAS}
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`
`afmmaiicm firgxrr: ihe FDA aha: States i? 3: 3 maximum of..%% resiciuai eth.ar1<3}.
`
`is: acceptable in
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`ifs I-zrili 0&1 producmz Therefore, such (fa :9-2.fm'::r2iz: amounts are viewed in the food indazstry
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`ménisszuée enough to be irreE»s:vas‘et,
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`As: E’$eaudoEz‘s reports
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`0&2 g3-;m::n§iaE}}i with a smaii
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`anmun: cf the phosphoiipid <.:c>r1taeiraing two of EBA and DE--if—\
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`about 0.1 to 1%), ii is my
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`opinion 3119,? this is mt»?
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`hi:,:E.0g,é.:;a1£y ef}3cti‘w2 amouzzi. As the <,;E:3.ims 0fs.he3 ‘348
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`are
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`d§rec‘:.ec?
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`to bioiogiealiy effeaive arrx0L-nts of his c.<>z'np0sit.ie»n,
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`‘-they
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`::zre: distinct:
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`from
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`Eieaudeén.
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`{In xwmmary,
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`ii
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`my op,%néa:3n that
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`ihe ‘348 patent describes arlei
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`3
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`‘r3i0i=0gi«;:.a3E;v'
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`erfeciéve amoum sf 3. phosphoiipid <::c:»m;30si1§on cont-2.ini:';_g EIPA zmdmr
`
`IDHA
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`This
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`intemre%.aiir:m is c;ensi.<;i'en=. wifh etamtiard praetie-.5 m {he feed -§m*E=.1siry,
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`‘Fu=.*-Lher,
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`I read ihe
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`Deciaraiicm of §;Ej-mi L. White, suhm.éIte::i Eviay 31, 353? i_,
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`to c«:3n<:hade that the Beazamin 0%}
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`drrxee not ezcmtain 3 °z:‘ic>.ic»,<..:ice_2.iE;,» ezffeeiive ammni of a ph<;-sphcdipéd coa'aiaér;§n.g {W0
`
`E3]-"A
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`and I;3H;-‘>,_
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`A350;
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`in my expert
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`s:>pin:\t-n_S
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`the G:mde—:-.rsen deeiarzatéon c<>rrob<';raies
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`the
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`2:,/9.S,‘,:, US, Food 3.31:5 Drug
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`‘ See, eg, Nutrational Labe.i~.ng arid i-Tcéazcation /—Xc:t (Nlfilisx) F<’.,eqmreme:“-is
` iiism :f.crma?z:»,’,7.v'.-as
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`ht?;s:x‘/\.v\vw.£’d;3.g,:zv»’ECECI/Enspecticmse/Enspeci@0210aides/ucmEMG98,hLrn1
`33$:
`;3CC-r3iSt.‘.(i
`:’x/{arch 4. 255‘ 5, Amsesadix B,‘-.
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`Se;55' Akcia‘ GRA§‘} Neiice (sf E.":1'i4./20 i O‘ Talnic i 9:? page 4 0f'38‘ .<\;3;>£zn<iEx C.
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`000006
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`Aiiegarziuey Basket N0. s.\€VI3Pa\H}{}i.»’a’}' U
`Serial
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`c.Qnch:s§.r.m of Dr. ‘White
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`it ernpleys a sen.<;ii'wc technique $0 aYc:g<-rdiy detect 2:
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`m:'rzz'mi2;
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`an"=s;>'-mt sf the phosphoiipid containing tum sf EPA and EIEHAV As {ha ‘348 patent is direcied
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`to biolqxgicafly effeaztéve amounts; of this compcsition; and Bemxdrs.-'E.r1 doas ma:-i mmain these
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`:s:'noun=;s, my opimc=;'a is that the chums of {E73 ‘348 patem are 2'ii:~3‘{£r1c1 fa‘-rma B€£‘.Y.i{.‘1C9§f1.
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`[R-;se:,=.-2§m;=er
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`p:xg.c~ie1*. és':£«';'5,5,E§0:‘.:3iEy blank]
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`
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`oooop7
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`000007
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`I i’L:rth<:1‘ dcszziare that 225$ statrzmems made her‘:-.in of my own E«:rxm=uiedge Es!‘-3 true, and thai am
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`s{a:e:';1er1I5 made an inE’”::-rn1:~.=.for2 and bi-Liief’ are 3:'2e.‘aiev=:d :0 be tuna, and furihzzr, that
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`est:
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`i:;:a?.«:<mems
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`made, with the knouvhadge éh’:~.?. wiiifui faizse :3tz1ten*1c.%nr.s :m<f 15:16:. Eikc: so
`rv
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`are punishablsz its}; {me 0:‘ i:npz'§sa3nm::.nt, or bah, undtzr Serziion E003 <3f’§"i[1::
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`:,sE‘i"ne United
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`Siams Code“.
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`an-vi
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`thai such wiEi.=fu.1 féise statenuazats may jeep:-;rr.1i;:<:
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`the vaiiciity
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`the
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`appiicatiorz 03' any paient issuing ths:'::=3.0n.
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`
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`F-3re.id0.'_m fiéhaiui-5.? Phi}.
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`Dated:
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`?»~'Ea:ci*-:29. J313
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`
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`000008
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